Home › NDC Lookup › Ingredients › Clonidine Hydrochloride › 70518-3162-04
clonidine hydrochloride .1 mg Tablet, 180-count — NDC 70518-3162-04 package photo

clonidine hydrochloride .1 mg Tablet, 180-count

by REMEDYREPACK INC. · 180 TABLET in 1 BOTTLE, PLASTIC (70518-3162-4)
NDC 70518-3162-04
🏷️ FDA NDC (as labeled) 70518-3162-4 billing pads the package segment with a zero
This package
Contains180-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.0688/unit — full pricing hub ↓
Also comes in: 30 tablets 70518-3162-00 30 tablets 70518-3162-01 30 tablets 70518-3162-02 30 tablets 70518-3162-07 90 tablets 70518-3162-05 180 tablets 70518-3162-06
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 70518-3162-4
Product NDC 70518-3162
11-digit billing NDC 70518316204
RxCUI 884173
UNII W76I6XXF06
Application # ANDA078895
SPL Set ID e5d24f52-e0c2-428d-b647-481d63ffd95f
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-19
Route ORAL
Dosage form TABLET
Substance CLONIDINE HYDROCHLORIDE
GCN Seq No 000346
GCN 01390
HICL code 000113
Ingredient (HICL) Clonidine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4B
Therapeutic class — specific (HIC3) Antihypertensives, Sympatholytic
AHFS code 24:24.00.00
AHFS class Central Alpha-Agonists
FDB label name CLONIDINE HCL 0.1 MG TABLET
FDB brand name Clonidine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70518-3162-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-3162-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Imidazoline receptor agonists, Other antimigraine preparations, Sympathomimetics in glaucoma therapy
How it works Adrenergic alpha2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderUNICHEM LABORATORIES LTD
FDA applicationANDA078895 (ANDA)
Labeler code70518
First marketedJul 2021
Product typeHuman Prescription Drug
Portfolio1,502 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CLONIDINE HCL 0.1 MG TABLET Ingredient Clonidine Hcl
📗 Our plain-language guide HelloPharmacist
  • You're right that it's used for several different conditions — that can be confusing. Depending on the product, clonidine is prescribed to lower high blood pressure in adults, to t...
  • What exactly is clonidine used for — I've seen it mentioned for totally different things?
  • Drowsiness is one of the most common side effects, especially when you first start or when your dose goes up. Many people find it eases a bit over time. Until you know how it affec...
  • Will clonidine make me too sleepy to function?
📖 Read our full Clonidine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Clonidine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clonidine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
ImprintU;135
Size8 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0688 $12.38 / 180 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clonidine Hydrochloride .1 mg 00228-2127-10 Actavis 100 tablets $0.025 AB Availability likely —
Clonidine Hydrochloride .1 mg 00904-7442-61 Major 100 tablets $0.025 AB Availability likely —
clonidine hydrochloride .1 mg 29300-0468-01 Unichem 100 tablets $0.025 AB Availability likely —
Clonidine Hydrochloride .1 mg 43547-0565-10 Solco 100 tablets $0.025 AB Availability likely —
clonidine hydrochloride .1 mg 50268-0192-15 AvPAK 50 tablets $0.025 AB Availability likely —
Clonidine hydrochloride .1 mg 52817-0180-00 TruPharma, 1000 tablets $0.025 — Availability likely —
Clonidine Hydrochloride .1 mg 58657-0647-01 Method 100 tablets $0.025 AB Availability likely —
Clonidine Hydrochloride .1 mg 59651-0232-01 Aurobindo 100 tablets $0.025 AB Availability likely —
Clonidine Hydrochloride .1 mg 60687-0113-01 American 100 tablets $0.025 AB Availability likely —
Clonidine Hydrochloride .1 mg 68001-0237-00 BluePoint 100 tablets $0.025 AB Availability likely —
Clonidine Hydrochloride .1 mg 00615-2572-05 NCS 15 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 46708-0306-10 Alembic 100 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 50090-5577-00 A-S 30 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 50090-6744-00 A-S 30 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 50090-6946-00 A-S 90 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 50090-7009-00 A-S 50 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 50090-7475-00 A-S 30 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 50090-7477-00 A-S 90 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 51655-0353-52 Northwind 30 tablets — AB FDA listed —
Clonidine hydrochloride .1 mg 51655-0445-18 Northwind 180 tablets — — FDA listed —
Clonidine Hydrochloride .1 mg 55154-0189-00 Cardinal 10 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 55154-2576-00 Cardinal 10 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 60760-0057-30 St. 30 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 60760-0992-30 St. 30 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 61919-0605-30 DirectRX 30 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 62332-0054-10 Alembic 100 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 63187-0202-30 Proficient 30 tablets — — FDA listed —
Clonidine Hydrochloride .1 mg 63629-2314-01 Bryant 500 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 63629-2315-01 Bryant 100 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 67296-2120-01 Redpharm 500 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 67296-2260-01 Redpharm 10 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 68071-2210-06 NuCare 60 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 68071-2699-01 NuCare 100 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 68071-3625-02 NuCare 120 tablets — AB FDA listed —
Clonidine hydrochloride .1 mg 68071-3987-01 NuCare 100 tablets — — FDA listed —
Clonidine hydrochloride .1 mg 68071-4545-01 NuCare 12 tablets — — FDA listed —
Clonidine Hydrochloride .1 mg 68071-4661-02 NuCare 120 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 68788-7145-01 Preferred 100 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 68788-8494-01 Preferred 100 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 70518-1035-05 REMEDYREPACK 90 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 70518-1962-00 REMEDYREPACK 30 tablets — AB Discontinued —
clonidine hydrochloride .1 mgthis 70518-3162-04 REMEDYREPACK 180 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 70518-4342-00 REMEDYREPACK 30 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 71205-0570-12 Proficient 12 tablets — AB FDA listed —
Clonidine hydrochloride .1 mg 71205-0588-12 Proficient 12 tablets — — FDA listed —
clonidine hydrochloride .1 mg 71335-0777-00 Bryant 24 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 71335-2266-00 Bryant 24 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 71335-2489-00 Bryant 24 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 72162-1679-01 Bryant 100 tablets — AB FDA listed —
Clonidine Hydrochloride .1 mg 72162-2609-00 Bryant 1000 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 72789-0091-08 PD-Rx 8 tablets — AB FDA listed —
clonidine hydrochloride .1 mg 76420-0066-01 Asclemed 100 tablets — AB FDA listed —
Clonidine hydrochloride .1 mg 76420-0283-01 Asclemed 100 tablets — — FDA listed —
clonidine hydrochloride .1 mg 83939-0005-01 VERITYRX, 1 tablet — AB FDA listed —
clonidine hydrochloride .1 mg 83939-0006-01 VERITYRX, 1 tablet — AB FDA listed —
clonidine hydrochloride .1 mg 87063-0181-01 ASCLEMED 100 tablets — AB FDA listed —
Clonidine hydrochloride .1 mg 87441-0023-01 Unit 30 tablets — — FDA listed —
Clonidine hydrochloride .1 mg 71335-0922-00 Bryant 24 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70518-3162-00 30 TABLET in 1 BLISTER PACK (70518-3162-0) 2021-07-19 Discontinued by firm
70518-3162-01 30 TABLET in 1 BLISTER PACK (70518-3162-1) 2023-02-27 Active
70518-3162-02 30 TABLET in 1 BLISTER PACK (70518-3162-2) 2023-06-11 Discontinued by firm
70518-3162-04 You're viewing this 180 TABLET in 1 BOTTLE, PLASTIC (70518-3162-4) 2024-10-15 Active
70518-3162-05 90 TABLET in 1 BOTTLE, PLASTIC (70518-3162-5) 2025-09-12 Active
70518-3162-06 180 TABLET in 1 BOTTLE, PLASTIC (70518-3162-6) 2025-10-31 Active
70518-3162-07 30 TABLET in 1 BOTTLE, PLASTIC (70518-3162-7) 2026-02-01 Active

Pack size FAQ

What quantity is in NDC 70518-3162-04?
NDC 70518-3162-04 is a 180-count package — 180 tablet in 1 bottle, plastic.
What is the difference between NDC 70518-3162-04 and NDC 70518-3162-00?
Both are clonidine hydrochloride .1 mg Tablet — the drug itself is identical. NDC 70518-3162-04 is the 180-count package, while NDC 70518-3162-00 is the 30 tablets package.
What NDC number is used to bill for this package of clonidine hydrochloride .1 mg Tablet?
Bill NDC 70518-3162-04 — the 11-digit billing format is 70518316204. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70518-3162-4, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70518-3162-04, written without dashes as 70518316204. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70518-3162-04, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (3162) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 30 tablets (70518-3162-00), 30 tablets (70518-3162-01), 30 tablets (70518-3162-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
REMEDYREPACK INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 26 words ▾

INDICATIONS AND USAGE Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.

⏱️ Dosage and Administration 175 words ▾

DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime).

Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness.

The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Patients with renal impairment may benefit from a lower initial dose.

Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).

⚠️ Warnings 202 words ▾

WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations.

Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine.

If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs' test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities ( i.e ., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud's phenomenon, syncope, and tachycardia.

Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.

🔄 Drug Interactions 178 words ▾

DRUG INTERACTIONS Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.

Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g. , digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ).

Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT- prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established.

🤰 Pregnancy 210 words ▾

Pregnancy Teratogenic Effects : Pregnancy Category C Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating.

Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 µg/kg). No adequate, well-controlled studies have been conducted in pregnant women.

Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ) . Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 21 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures.

Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage.

Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial.

Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy.

Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions.

The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets acts relatively rapidly.

The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45 0 tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise.

Tolerance to the antihypertensive effect may develop in some patients, necessitating a reevaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated.

Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 µg. The absolute bioavailability of clonidine on oral administration is 70% to 80%.

Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function.

Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours.

About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function.

A further rise in the plasma levels will not enhance the antihypertensive effect.

📦 How Supplied / Storage and Handling 132 words ▾

HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are supplied as: 0.1 mg White round shaped, biconvex, scored tablets, debossed with "U" and "135" on either side of breakline on one side and plain on other side. NDC: 70518-3162-00 NDC: 70518-3162-01 NDC: 70518-3162-02 NDC: 70518-3162-03 NDC: 70518-3162-04 NDC: 70518-3162-05 NDC: 70518-3162-06 NDC: 70518-3162-07 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 100 in 1 BOTTLE PLASTIC PACKAGING: 180 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 180 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC Store at 20oto 25oC (68o to 77oF) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr.

Suite #4 Indiana, PA 1-724-465-8762

📋 Description 102 words ▾

DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, sodium starch glycolate, glycerin, lactose monohydrate, magnesium stearate, povidone.

Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.

Chemical Structure

💬 Information for Patients 104 words ▾

Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70518-3160-00 · REMEDYREPACK 70518-3164-00 · REMEDYREPACK →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.